Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study.

HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses.

The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients’ data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.

To investigate the change in anticholinergic burden over a 5 year period in relation to the health characteristics of older adults.

Using data from the MultiCare Cohort Study (2008–2013), a prospective observational cohort study based on patient data from 158 general practices

Primary care in Germany.

3189 multimorbid adults aged 65 to 85 years

The primary outcome was the change in the anticholinergic burden score (ACB) over a 5 year period. The ACB was defined as the dependent variable and was calculated by including all anticholinergic drugs prescribed to participants during the study period. Independent variables included age, sex, education (according to CASMIN), depressiveness (GDS), cognitive function (LDST), quality of life (EQ5D-3L) and the number of diseases weighted by severity. We performed multilevel mixed-effects multivariable linear regression analyses.

A total of 7068 observations were analysed during three follow-ups. The mean age of the participants was 74.4±5.2 years and 59.3% were female. The mean ACB score was 1.5±1.7 at baseline and did not change significantly over time. In contrast, a higher severity-weighted number of diseases (coefficient: 0.08, 95% CI: 0.05/0.10, p

Our results show that anticholinergic prescribing increases despite the deteriorating health status of older adults, which may lead to higher hospitalisation and mortality rates. New practice recommendations for general practitioners may be helpful in raising their awareness of cumulative ACB and enabling them to discontinue or reduce the dose of some anticholinergics where possible. However, further research is needed to assess the impact of our findings on prescribing behaviour in primary care.

ISRCTN89818205.

For transgender and gender-diverse (TGD) people, it is known that there is a lack of healthcare professionals with experience in trans healthcare. This may result in either inadequate provision of healthcare or in an increased seeking of adequate trans healthcare. Little is known about healthcare services utilisation and resulting costs in treatment-seeking TGD people with gender incongruence or gender dysphoria (GIC/GD). Therefore, the aim of this study was to determine the excess costs associated with GIC/GD in Germany.

In a secondary analysis, baseline data of a randomised controlled trial with a sample of TGD people with GIC/GD were combined with data of a telephone survey conducted in a representative sample of the general German population. The data sets were matched using entropy balancing. Self-reported healthcare services utilisation was valued by standardised unit costs for the German healthcare system, and absenteeism from work and unemployment were valued with the gross hourly wage of persons in manufacturing and services sectors.

TGD people with GIC/GD living at least 50 km outside Hamburg in the federal state Bremen, Mecklenburg-Western Pomerania, Lower Saxony or Schleswig Holstein and the German general adult population.

Treatment-seeking TGD people with GIC/GD (n=167) and people of the general German population (n=2811).

6-month excess healthcare costs and indirect costs from a societal perspective were calculated for the year 2020 using two-part models with logit specification for the first part and a generalised linear model with gamma family and log link function for the second part.

The total 6-month excess costs associated with GIC/GD from a societal perspective were estimated to be 672 (95% CI: –3315 to 4657; p=0.741) per person. The direct excess healthcare costs were estimated to be 2 (–1115 to 1119; p=0.977) and the indirect excess costs due to absenteeism from work and unemployment were 669 (–3031 to 4370; p=0.723) per person. The total excess costs associated with GIC/GD in trans men, trans women and non-binary people were estimated to be –5572 (–12 232 to 1088), 4238 (–1694 to 10 170) and 3041 (–4268 to 10 351) per person (all with p>0.05), respectively.

The total 6-month costs in TGD people with GIC/GD did not differ statistically significantly from the costs in the general German population. Indirect excess costs due to absenteeism from work accounted for the largest part of the excess costs associated with GIC/GD, yet with wide 95% CIs. Potential causes of absenteeism from work, such as experienced or expected discrimination, need to be identified and addressed so that TGD people can experience a healthy work environment.

NCT04290286.